AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - Generic Drug Details

What are the generic sources for amlodipine besylate; atorvastatin calcium and what is the scope of patent protection?

Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Dr Reddys, Mylan, Neocubes Pharma, and Pharmacia, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	8
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
DailyMed Link:	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM at DailyMed

Recent Clinical Trials for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Dr. Reddy's Laboratories Limited	Phase 1

See all AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM clinical trials

Pharmacology for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker HMG-CoA Reductase Inhibitor
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	2.5 mg/40 mg	021540	1	2009-09-17
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	5 mg/80 mg	021540	1	2009-04-07
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	5 mg/10 mg 5 mg/20 mg 5 mg/40 mg 10 mg/10 mg 10 mg/20 mg 10 mg/80 mg	021540	1	2006-12-29

US Patents and Regulatory Information for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	200465-011	Nov 29, 2013	AB	RX	No	No
Mylan	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	200465-006	Nov 29, 2013	AB	RX	No	No
Apotex	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	205199-007	Nov 18, 2019	AB	RX	No	No

Expired US Patents for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-006	Jan 30, 2004	5,969,156*PED
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-008	Jan 30, 2004	RE40667*PED
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-002	Jan 30, 2004	RE40667*PED

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Atorvastatin Calcium

Last updated: July 29, 2025

Introduction

Amlodipine besylate and atorvastatin calcium stand as cornerstone medications in cardiovascular therapy, primarily targeting hypertension and hyperlipidemia, respectively. Their established efficacy, safety profiles, and widespread adoption influence market trends and financial trajectories significantly. This report examines the current market dynamics, growth drivers, competitive landscape, and financial outlook for these pharmaceuticals, offering vital insights for stakeholders.

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Market Overview

Amlodipine Besylate

Amlodipine besylate, a long-acting calcium channel blocker, remains among the top prescribed antihypertensive agents globally. Its comprehensive approval across various countries and inclusion in essential medicines lists bolster its market presence. The drug's effectiveness in reducing blood pressure, coupled with favorable tolerability, sustains its demand.

Atorvastatin Calcium

Atorvastatin calcium, a statin class lipid-lowering agent, revolutionized hyperlipidemia management following its blockbuster status post-approval. Despite newer agents and generics, atorvastatin sustains a substantial share, given its proven efficacy in lowering LDL cholesterol and reducing cardiovascular events.

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Market Drivers

Growing Global Burden of Cardiovascular Diseases (CVDs)

The rising incidence of hypertension, hyperlipidemia, and CVDs, driven by lifestyle factors and aging populations, underpins demand for these medications. According to WHO, CVDs account for approximately 17.9 million deaths annually, fueling the prescription of antihypertensives and statins.

Expanding Access in Emerging Markets

Developing economies are witnessing increased healthcare infrastructure, better diagnostic capabilities, and health awareness, leading to higher drug penetration. Governments and NGOs support access to essential medicines, including amlodipine and atorvastatin.

Patent Expirations and Generic Competition

The expiration of patents in recent years for both drugs has significantly shifted market dynamics, fostering generic proliferation. Generics reduce prices and boost utilization, particularly in price-sensitive markets, expanding patient access.

Innovations and Combination Therapies

Development of fixed-dose combinations (FDCs), integrating amlodipine with other antihypertensives or atorvastatin with other lipid-lowering agents, enhances adherence and improves outcomes, further strengthening market growth.

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Market Challenges

Emergence of New Therapeutics

Introduction of PCSK9 inhibitors and novel antihypertensive agents presents therapeutic competition, especially in cases resistant to conventional therapies, potentially impacting the market shares of amlodipine and atorvastatin.

Pricing and Reimbursement Policies

Price pressures, driven by healthcare cost containment measures and aggressive generic strategies, could constrain margins, particularly in public healthcare systems.

Regulatory and Safety Concerns

Despite favorable safety profiles, rare adverse events or new safety signals could influence prescribing practices and market dynamics.

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Financial Trajectory Analysis

Revenue Trends and Projections

Based on recent market research, the combined global revenue for these drugs exceeds USD 20 billion annually, with a compound annual growth rate (CAGR) forecast of approximately 4-6% over the next five years. The growth is primarily driven by expanding markets in Asia-Pacific and Africa.

Impact of Patent & Regulatory Milestones

Patent losses have catalyzed price reductions but also opened avenues for volume-driven growth through increased accessibility. Regulatory approvals for new formulations and indications will further influence revenue streams.

Pricing Strategies & Market Penetration

Manufacturers employing aggressive pricing, partnerships with government bodies, and local manufacturing capacity bolster market share. Biosimilar entrants, especially in atorvastatin, are expected to exert downward pressure on prices.

Manufacturing & Supply Chain Considerations

Supply chain robustness and cost efficiencies remain critical, especially amid geopolitical tensions and global disruptions, influencing profit margins.

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Regional Market Insights

North America

The mature market continues to grow modestly, driven by high adoption rates, technological innovations, and generic competition. The U.S. market alone accounts for over 50% of global sales.

Europe

Regulatory compliance and reimbursement landscapes influence market size but remain lucrative due to high disease prevalence.

Asia-Pacific

The fastest-growing region, with increasing healthcare infrastructure, urbanization, and patient awareness, anticipates a CAGR of 8-10%. Market expansion here is pivotal to overall growth trajectories.

Latin America and Middle East & Africa

Emerging markets with expanding access but often constrained by affordability challenges. Generics presence is significant, offering competitive pricing.

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Future Outlook

Market Expansion Opportunities

• Personalized Medicine: Tailoring therapy based on genetic and biomarker profiling offers potential for optimized treatment, though commercial uptake remains in early stages.
• Digital & Telehealth Integration: Enhances adherence monitoring and improves patient outcomes, indirectly boosting drug demand.
• Combination Therapies: Increasing use of FDCs to manage comorbid hypertension and hyperlipidemia enhances market attractiveness.

Potential Risks

• Regulatory Hurdles: Stringent approvals or withdrawal of certain formulations could impact sales.
• Generic Market Saturation: Price erosion due to multiple generics may affect profit margins.
• Emerging Competitors: Novel therapeutics or biologics may encroach upon traditional small-molecule markets.

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Key Takeaways

• The global market for amlodipine besylate and atorvastatin calcium remains robust with steady growth driven by rising CVD prevalence, aging populations, and expanding access in emerging economies.
• Patent expirations have democratized market access via generics, leading to increased volume sales but compressing margins.
• Innovation through FDCs and formulation enhancements sustains competitive advantages and facilitates adherence.
• Strategic positioning in high-growth regions, especially Asia-Pacific, offers significant revenue potential.
• Regulatory, pricing, and competitive challenges require proactive management to sustain financial performance.

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FAQs

1. How will patent expirations influence the market for amlodipine and atorvastatin?
   Patent expirations have led to a surge in generic competition, drastically reducing drug prices and increasing accessibility. While this constrains per-unit margins, overall sales volumes tend to rise, balancing revenue streams. Market players focusing on manufacturing efficiencies and portfolio diversification can offset margin reductions.

2. What role do combination therapies play in the future of these drugs?
   Fixed-dose combinations that include amlodipine or atorvastatin improve patient adherence, simplify treatment regimens, and address comorbid conditions more effectively. Their adoption is expected to grow, especially in markets emphasizing chronic disease management.

3. How significant is the emerging markets segment for these drugs?
   Emerging markets contribute significantly to future growth, driven by improving healthcare infrastructure, growing disease prevalence, and increasing affordability. Targeted pricing strategies and local manufacturing are essential in leveraging these opportunities.

4. What competitive strategies are pharmaceutical companies employing?
   Companies are investing in developing novel formulations, expanding into new regional markets, forming strategic alliances, and pursuing regulatory approvals for new indications. Focus on biosimilars and smart marketing targeting physicians and payers also enhances competitiveness.

5. What are the potential regulatory challenges impacting these markets?
   Regulatory agencies are increasingly scrutinizing drug safety and efficacy, requiring comprehensive clinical data. Entry barriers include patent litigations, approval delays, and evolving standards, which can influence market entry timing and profitability.

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References

[1] World Health Organization. Cardiovascular diseases (CVDs). (2021).
[2] MarketWatch. Global Amlodipine and Atorvastatin Market Trends & Forecasts. (2022).
[3] EvaluatePharma. 2023 World Preview.
[4] IMS Health. Cardiovascular Market Insights. (2021).
[5] FDA. drug approvals and safety guidance documents.